Question: Why is there a discrepancy between USP <797> and the BUDs provided in the official USP Compounding Monographs?
Answer:
Let’s look at both the chapter and the monographs to see what is presented.
USP <797>, Section 14.3 Establishing a BUD for a CSP states:
“Table 11 establishes the longest permitted BUDs for Category 2 CSPs.�
First, let’s look at the BUDs in Table 11:
For Aseptically processed CSPs sterility tested and not sterility tested, the maximum BUDs are:
Storage Condition | Sterility Tested | Not Sterility Tested |
Controlled Room Temperature | 30 Days | 1 or 4 Days |
Refrigerated Temperature | 45 Days | 4 or 10 Days |
For Terminally sterilized CSPS sterility tested and not sterility tested, the maximum BUDs are:
Storage Condition | Sterility Tested | Not Sterility Tested |
Controlled Room Temperature | 45 Days | 14 Days |
Refrigerated Temperature | 60 Days | 28 Days |
Second, let’s look at the BUDs (Days) in the official USP sterile compounding monographs:
Preparation | Room Temperature | Refrigerated Temperature |
Cefazolin Ophthalmic Solution | | 5 |
Cisapride Compounded Injection, Veterinary | | 90 |
Cyclosporine Compounded Ophthalmic Solution, Veterinary | 180 | |
Dexamethasone Sodium Phosphate Compounded Injection | 90 | |
Fentanyl Citrate Compounded Injection | 90 | 90 |
Fentanyl Citrate and Bupivacaine Hydrochloride Compounded Injection | 90 | 90 |
Fentanyl Citrate and Ropivacaine Hydrochloride Compounded Injection | 90 | 90 |
Guaifenesin Compounded Injection, Veterinary | 90 | |
Hydrochloric Acid Compounded Injection | 120 | 120 |
Methylene Blue Injection, Veterinary | 365 | |
Morphine Sulfate Compounded Injection | 90 | |
Potassium Phosphates Compounded Injection | 120 | |
Sodium Phosphates Compounded Injection | 120 | |
Urea Compounded Irrigation | 60 | 60 |
Voriconazole Compounded Ophthalmic Solution, Veterinary | | 60 |
Third, it appears that the above official USP formulations will be limited to the BUDs in Table 11 and pharmacists CANNOT use the BUD that is provided using stability-indicating analytical methods in the official USP compounding monograph.
Final Comment: This is another example of where USP <795>, <797>, and <800> are not all scientifically based and are inconsistent with each other.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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REMINDER: For those State Boards of Pharmacy that are not adopting the USP chapters and are preparing their own or using their own modifications of the chapters, easily-modifiable alternative versions of Chapters <795>, <797>, and <800> have been prepared and are available as a free download for use by state boards of pharmacy to modify for their individual states at the following website.
CompoundingToday.com
Also, you may wish to download these alternatives and send them to your state board of pharmacy for consideration. Also, send the following Sterile Compounding Consensus Statement, available at the same website.
Note: The Sterile Compounding Consensus Statement representing a digest of important changes found in the recently published final version of USP Chapter <797> has just been released, and is available on the Compounding Today website at: CompoundingToday.com
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